A Phase 1, First-in-Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has recurrent or metastatic solid tumors with HER2 expression and has disease progression after treatment, is intolerant to treatment, or is contraindicated with available anti-cancer therapies known to confer benefit, based on investigator's judgement. Note: Participants must have HER2 positivity per the results of their most recent tumor tissue testing, defined as IHC 3+ or IHC 2+ in combination with in situ hybridization (ISH)+. Participants with ERBB2-activating mutations or ERBB2 gene amplification in the absence of HER2 positivity are considered ineligible.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Participant must have measurable disease as defined by RECIST version 1.1.

• Participant has fresh tumor biopsy tissue available for submission to central laboratory. If obtaining fresh tumor tissue is medically contraindicated, archival tumor tissue can be submitted following written approval of the request by the study Medical Monitor. Samples must be obtained after the participant's most recent HER2-targeting therapy unless determined to be medically contraindicated after discussion with the medical monitor.

Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
University of South California
RECRUITING
Los Angeles
Stanford University Medical Center
RECRUITING
Stanford
Florida
AdventHealth Celebration
RECRUITING
Celebration
Georgia
Emory Healthcare, Emory Clinic
RECRUITING
Atlanta
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
New York University Medical Oncology Associates
RECRUITING
New York
Ohio
The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Tennessee
Tennessee Oncology, PLLC
RECRUITING
Nashville
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
June Buchanan
medicalinformation@mersana.com
617-844-8613
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2027-04
Participants
Target number of participants: 162
Treatments
Experimental: XMT-2056
XMT-2056 alone (monotherapy)
Sponsors
Leads: Mersana Therapeutics

This content was sourced from clinicaltrials.gov